Senior Technical Lead - MDR, 510(k), DHF Remediation

Job Summary

The Senior Technical Lead in MDR plays a crucial role in managing technology across complex projects, providing expert technical guidance to enhance team capabilities and ensure successful project delivery. This position demands advanced proficiency in regulatory compliance and technical standards, crucial for driving project success in a highly regulated environment.

Key Responsibilities

1. Provide Technical Guidance To A Team Of Developers In Mdr, Enhancing Their Knowledge Of Regulatory Requirements And Increasing Productivity Through Effective Mentoring And Training.

2. Conduct Comprehensive Code Reviews Using Tools Like Sonarqube And Oversee Quality Assurance Processes, Ensuring The Implementation Of Best Practices And Coding Standards For High-Quality Outcomes In Complex Regulatory Projects.

3. Ensure Compliance With Iso 13485 And Ivdr Standards In The Assigned Module And Participate In Technical Discussions As A Consultant For Feasibility Studies, Analyzing Technical Alternatives, Assessing Risks, And Providing Breakdowns For Estimations.

4. Collaborate With Stakeholders To Define Project Scope, Objectives, And Deliverables While Preparing And Submitting Status Reports To Minimize Exposure And Facilitate The Closure Of Escalations In Mdr Projects.

Skill Requirements

1. Advanced Proficiency In Medical Device Regulation (Mdr) And Familiarity With Key Regulatory Frameworks (Iso 13485, Ivdr).

2. Strong Understanding Of Software Development Best Practices, Quality Assurance Methodologies, And Coding Standards.

3. Excellent Analytical And Problem-Solving Skills, With The Ability To Assess Technical Risks And Make Informed Decisions.

4. Proficient In Project Management Tools And Methodologies To Effectively Track Project Progress And Stakeholder Communication.

Other Requirements

1. Optional But Valuable Certifications: Certified Quality Auditor (Cqa), Iso 13485 Lead Auditor, Or Relevant Certifications In Medical Device Regulatory Affairs.